EP4192393A1 - Verfahren zur herstellung eines individuellen 3d-gedruckten bioresorbierbaren keramischen knochenimplantats zur verwendung in der traumatologie und orthopädie - Google Patents

Verfahren zur herstellung eines individuellen 3d-gedruckten bioresorbierbaren keramischen knochenimplantats zur verwendung in der traumatologie und orthopädie

Info

Publication number
EP4192393A1
EP4192393A1 EP21856570.3A EP21856570A EP4192393A1 EP 4192393 A1 EP4192393 A1 EP 4192393A1 EP 21856570 A EP21856570 A EP 21856570A EP 4192393 A1 EP4192393 A1 EP 4192393A1
Authority
EP
European Patent Office
Prior art keywords
implant
vol
composition
powder base
hydroxyapatite
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21856570.3A
Other languages
English (en)
French (fr)
Inventor
Arkadii BOHDAN
Vadym VOLKOV
Oleg ROGANKOV
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Advanced Development Of Additive Manufacturing Inc
Original Assignee
Advanced Development Of Additive Manufacturing Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Development Of Additive Manufacturing Inc filed Critical Advanced Development Of Additive Manufacturing Inc
Publication of EP4192393A1 publication Critical patent/EP4192393A1/de
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/10—Ceramics or glasses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/20—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/425—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of phosphorus containing material, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
    • B29C64/118—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material using filamentary material being melted, e.g. fused deposition modelling [FDM]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/20—Apparatus for additive manufacturing; Details thereof or accessories therefor
    • B29C64/205—Means for applying layers
    • B29C64/209—Heads; Nozzles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/30—Auxiliary operations or equipment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/30—Auxiliary operations or equipment
    • B29C64/386—Data acquisition or data processing for additive manufacturing
    • B29C64/393—Data acquisition or data processing for additive manufacturing for controlling or regulating additive manufacturing processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y40/00—Auxiliary operations or equipment, e.g. for material handling
    • B33Y40/20—Post-treatment, e.g. curing, coating or polishing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
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    • A61F2002/30943—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using mathematical models
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • A—HUMAN NECESSITIES
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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    • A61L2400/00—Materials characterised by their function or physical properties
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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    • B33Y70/00—Materials specially adapted for additive manufacturing
    • B33Y70/10—Composites of different types of material, e.g. mixtures of ceramics and polymers or mixtures of metals and biomaterials

Definitions

  • Tissue engineering is an interdisciplinary field that applies the principles of engineering, medicine, basic sciences to develop tissue substitutes - implants that restore, maintain or improve the function of human tissues.
  • Large-scale cultivation of human, animal or artificial origin cells can provide materials to replace damaged components in humans.
  • Natural or synthetic materials when implanted into the human body as temporary structures provide a framework that allows the body’s own cells to migrate, differentiate, grow and form new tissues, while the framework itself is gradually absorbed by the body.
  • the requirements for ceramic implants are: high porosity, an open pore network for cell growth and transfer of nutrients and metabolic waste; biocompatibility and bioresorbability with controlled rates of decomposition and resorption to match the rate of tissue replacement in the body; suitable surface composition for cell attachment, proliferation and differentiation; mechanical properties corresponding to the tissues at the site of implantation.
  • the structure of the implant must protect the interior of the proliferating cells of the pore network and their extracellular matrix from mechanical overload for a sufficient period of time. This is especially important for supporting tissues such as bones and cartilage.
  • biodegradable properties of the implant in the present invention allow the patient to recover with one operation without the need for additional medical measures as opposed to using metal-containing (e.g. Ti) implants that generally might lead to long-term issues, especially in cases where patients are immunosuppressant.
  • metal-containing implants e.g. Ti
  • Figure 1 is an example of a 3d-printed implant of a patella according to the present invention.
  • Figure 2 is an example design of the implant of a patella according to the present invention.
  • Figure 3 is an example design of a proximal part of the radial bone with the head of the radial bone according to the present invention.
  • Figure 4 is an example of a printed proximal part of the radial bone with the head of the radial bone according to the present invention.
  • Figure 5 is an example process for replacing a bone defect using the method and composition of the present invention.
  • the implants of the present invention are adopted by and transformed by human tissue into human bone and do not require repeated surgical intervention, thereby improving the quality of treatment and facilitating the patient’s healing process.
  • the present invention eliminates the need to traumatize a patient for the purpose of bone marrow autoplasty.
  • the method and resulting mold of the present invention provides sufficient strength indicators to withstand implant loads for use in orthopedic surgery.
  • composition of the present invention was methodically selected so that it doesn't have allergic, toxic, oncogenic properties.
  • the 3D modeling technique of the present invention allows the medical community to perform an implant in any size and shape, taking into account the need for a particular clinical case.
  • Biodegradable materials irrespective of their constituent form, are expected to degrade progressively over a period of time to assist as scaffolds or for the healing process.
  • transplant is intended to describe one of the well-known shaped transplants to be placed into the bone defect.
  • biocompatible is intended to describe the ability of material to perform as a substrate that will support the appropriate cellular activity, including the facilitation of molecular and mechanical signalling systems, in order to optimise tissue regeneration, without eliciting any undesirable effects in those cells, or inducing any undesirable local or systemic responses in the eventual host.
  • borosilicate glass is intended powder mix of Silica oxide(IV), Aluminum oxide(lll), Barium oxide(lll), Calcium oxide(ll), Sodium oxide, Potassium oxide in designated proportions.
  • bioresorbable is intended the property of the material to be fully resorbed by the body enzymes to the simple metabolites that are presented in the human body.
  • Ceramic properties is intended the state of the product that is near to an inorganic compound of metal, metalloid and nonmetal with ionic or covalent bonds.
  • the present invention method utilizes a binder-jet printing method.
  • the method is one of a number of additive manufacturing processes that can be used to form three- dimensional objects such as medical implant molds by controlled injection of a binder from a moving print head onto layers of ceramic powder fed by a system of moving platforms and a print shaft.
  • the print head produces movements along the X and Y axes.
  • the movement along the Z axis occurs due to the synchronous movement of the moving platforms.
  • the feed platform rises to a fixed height up, the shaft takes the required amount of powder and evenly applies it to the printing surface, then the print head injects binder at specified points with high accuracy, the printing platform plunges down a fixed distance and the process repeats.
  • the printer draws the engineered model one layer at a time.
  • the BJP method involves extruding the binder through a nozzle and binding the powder base at the injection site.
  • the nozzle is part of the extruder head, the binder is fed into the print head through the feed system from the reservoir.
  • the present method of making a ceramic powder for 3D printing includes mixing an initial powder base mixture comprising the composition having 64% of hydroxyapatite with 27% of borosilicate glass and with 9% of maltodextrin by loading into a V-shaped mixer and mixing it for 2 hours.
  • the obtained mixed printing powder is loaded into the 3D-printer feed chamber to make the 3D printed mold.
  • the calcium hydroxyapatite is the chemical compound of chemical formula Ca (PO4)e (OH)? wherein the Ca/P ratio is 1.63-1.75.
  • the borosilicate glass is the chemical compound of SiO? AI2O3 B2O3 CaO Na2O K2O.
  • maltodextrin is a polysaccharide that is produced from vegetable starch by partial hydrolysis, wherein maltodextrin has the chemical formula of C(6n> H ⁇ ion+2) O(5n+1>.
  • the present invention uses a binder solution used for extruding onto a printing surface via the printing head to bind powder particles in designated locations.
  • the binder composition is 40 vol% of ethylene glycol, 10 vol% of isopropyl alcohol, 10 vol% of glycerin, 3 vol% of cocoate, and 300 vol% of distilled water plus remainder proportion of impurities.
  • the design begins with creating a 3D model.
  • a patient’s CT/MRI images of the damaged area are processed using specialized program software; localization and size of the injury are assessed; and, on the basis of the obtained data, a 3D image of the symmetrical bone is taken from the other side and mirrored. If the fracture of the right humerus requires a repair, then an observation is made of the necessary area of the left humerus with the mirror image.
  • a CT / MRI scan of the patient is taken before an injury; the resulting image is cropped to include only the necessary anatomical structures. Then the obtained 3D model is converted to an “.stl” format and is prepared for further printing. During all the manipulations, the scale and size of the 3D model are preserved. The model is imported into the software of a 3D printer to further the printing.
  • a standard software package automatically generates support when needed. An example of the support might be in the additional construction model, which fixates the model during the printing and sintering processes and does not connect with the body of an implant.
  • the resulting object remains in the printing chamber for 8 hours for better binding, and for better interconnectedness between powder particles after the printing process. Then the object is dried in a drying chamber at 80°C for 8 hours to evaporate excess binder from the object. Next comes the process of dedusting.
  • Dedusting is the removal of excess powder from the surface of the object using a spray gun with compressed air and a set of brushes. Then the object is sent for firing in a muffle furnace at a peak temperature of 1150°C for 12 hours. After firing, the finished implant is in the form of a monolithic structure with an open porous system. Information for optimal processing parameters is described in Table 2.
  • Open porosity is achieved due to the presence of maltodextrin in the composition. It is used to bind the powder base by injecting a binder with which the maltodextrin comes into contact and holds the surrounding powder particles together. Since the decomposition temperature of maltodextrin is 350°C, during firing, it decomposes and leaves cavities that are interconnected and form an open pore system.
  • the three-dimensional ceramic matrix of the implant has the kinetics of degradation and resorption up to 18 months and the ability to maintain a given shape under the action of biomechanical stress.
  • Such a composite material improves the biocompatibility and integration of hard tissues.
  • Hydroxyapatite provides an artificial bone matrix which stimulates the vascularisation and differentiation of macrophages and mesenchymal stem cells to osteogenic cells and is neutral for the human body.
  • the main products of hydroxyapatite resorption help to buffer the byproducts of the acidic resorption of aliphatic polyester and thereby help avoid the formation of an unfavorable environment for the cells of hard tissues due to the low pH.
  • the components of borosilicate glass provide increased bioactivity of the implant and stimulate the growth of osteoblasts on its surface. Final result of the treatment with the proposed implant is completely regenerated bone in the place of former bone defect.
  • the present invention uses binder-jet printing to process a bioresorbable composite of two biomaterials, borosilicate glass and hydroxyapatite, to meet all the criteria for use in tissue engineering applications.
  • Hydroxyapatite range of ⁇ 60% yields a mold that has inefficient properties, because the implant shows low cell activity according to the tests.
  • Hydroxyapatite range of >70% yields a mold that has inefficient properties, because the implant has too low a density according to the tests.
  • Borosilicate glass/45S5 Bioglass range of ⁇ 25% yields a mold that has inefficient properties, because the implant does not properly sinter and loses its structure according to the tests.
  • Borosilicate glass/45S5 Bioglass range of >35% yields a mold that has inefficient properties, because the implant shows low cell activity according to the tests.
  • Maltodextrin range of >5% yields a mold that has inefficient properties, because the printing powder at the printing stage is not held together by a binder according to the tests.
  • Sintering temperature of >1200°C yields a mold that has inefficient properties, because hydroxyapatite crystallizes after 1200°C which leads to a loss of biologically active properties of hydroxyapatite according to the tests.
  • a binder in composition comprising 40 vol% of ethylene glycol, 10 vol% of isopropyl alcohol, 10 vol% of glycerin, 3 vol% of cocoate, 300 vol% of distilled water in designated proportions.
  • the 3D implant printing steps a. Setup of the 3D printer with the preset parameters b. Simulation of a 3D model in Autodesk 3DS Max using the results of a patient's CT/MRI examination c. Loading the printing powder into the printer feed chamber. d. Downloading 3D model to a printer e. Printing the implant f. Holding the implant in the mass of the printed powder for better binding of particles for 8 hours g. Drying the implant in the drying chamber at 80°C for 2 hours h. Removing the excess powder from the surface of the implant using a spray gun with compressed air and a set of brushes i.

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EP21856570.3A 2020-08-10 2021-08-10 Verfahren zur herstellung eines individuellen 3d-gedruckten bioresorbierbaren keramischen knochenimplantats zur verwendung in der traumatologie und orthopädie Pending EP4192393A1 (de)

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US20180296343A1 (en) * 2017-04-18 2018-10-18 Warsaw Orthopedic, Inc. 3-d printing of porous implants
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